Medication info
Donapezil 10 mg (Donepezil Hydrochloride Hydrate)

Donapezil 10 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 tablet
Manufacturer / importer
(주)비씨월드제약
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202003140 · Approved 2020.04.28 · Insurance code 653103600

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If disturbing dreams, nightmares, or sleep disturbances occur, consider administering it in the morning. After administering 5 mg for 4 to 6 weeks and evaluating the clinical response, the dose may be increased to 10 mg. When increasing the dose to 10 mg per day, caution should be exercised regarding gastrointestinal adverse reactions. Underweight elderly women should not exceed a dose of 5 mg per day.
Child dose
There is no experience of use in children.

Ingredients

Manufacturer
(주)비씨월드제약

Efficacy & effects

Improvement of symptoms of Alzheimer's type dementia

  • Symptoms of Alzheimer's type dementia
View approved original text

The medicine used for the treatment of symptoms of Alzheimer's type dementia helps improve memory loss and cognitive impairment. This drug works to slow the progression of symptoms by balancing neurotransmitters in the brain and reduces discomfort in daily life. It also contributes to maintaining the overall mental function of patients and enhancing their quality of life. Thus, it is used to alleviate and treat the symptoms of Alzheimer's type dementia.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If disturbing dreams, nightmares, or sleep disturbances occur, consider administering it in the morning. After administering 5 mg for 4 to 6 weeks and evaluating the clinical response, the dose may be increased to 10 mg. When increasing the dose to 10 mg per day, caution should be exercised regarding gastrointestinal adverse reactions. Underweight elderly women should not exceed a dose of 5 mg per day.

Child dose

There is no experience of use in children.

Precautions

This drug contains Donepezil Hydrochloride Hydrate as its main ingredient and is used in the treatment of Alzheimer's type dementia symptoms. First, this drug should not be used in certain patients. For example, patients allergic to this drug or its components, women who are pregnant or may become pregnant, and breastfeeding women should not take this drug. Additionally, individuals with lactose intolerance or genetic disorders related to lactose should not take this drug. Patients with heart disease should exercise particular caution when using this drug as it may slow the heart rate or cause arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or those with a history of peptic ulcers should use this medicine with caution due to the risk of gastrointestinal bleeding or exacerbation of ulcers. Patients with asthma or obstructive lung disease should be cautious as this drug may exacerbate symptoms due to bronchoconstriction or increased mucus secretion. Patients with extrapyramidal disorders such as Parkinson's disease may find that this drug exacerbates their symptoms, so it should be administered carefully. This drug can have various side effects. The most serious side effects reported include heart problems (fainting, bradycardia, heart block, etc.), gastrointestinal bleeding, liver dysfunction, cerebrovascular problems, extrapyramidal symptoms, neuroleptic malignant syndrome, and rhabdomyolysis. Additionally, various neurological and gastrointestinal adverse reactions such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, anxiety, myalgia, etc., may occur. This drug is approved only for use in patients with Alzheimer's type dementia and is not recommended for other forms of dementia or memory disorders. Treatment should always be conducted under the supervision of an experienced physician, and the condition of medication administration should be regularly monitored by caregivers. This drug may cause cardiac conduction disorders, so patients with heart disease or a history of QT interval prolongation should be monitored through electrocardiograms. Caution is needed during the initial phase of administration or when altering the dose, as it may affect the ability to drive or operate machinery. Additionally, this drug may interact with various medications, so patients taking other drugs must inform their physician or pharmacist. In particular, there may be changes in efficacy when combined with drugs related to CYP3A4 and CYP2D6 enzymes. Women who are pregnant or breastfeeding are advised not to use this drug; if it is absolutely necessary, breastfeeding should be stopped. The safety for use in children has not been established, so this drug should not be used in pediatric patients. In the case of overdose, severe symptoms such as nausea, vomiting, bradycardia, and respiratory depression may present, requiring immediate treatment at a medical facility. Finally, this drug should be stored out of reach of children, and transferring it to another container should be avoided as it may lead to decreased quality or accidents.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, fainting, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral epilepsy, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (motor dysfunction, ataxia, movement disorders, dystonia, tremors, involuntary movements, walking difficulties, abnormal posture,

Mild side effects

  • Nausea
  • vomiting
  • dizziness
  • diarrhea
  • insomnia
  • abdominal pain
  • loss of appetite
  • headache
  • fatigue
  • drowsiness
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  • anxiety
  • hallucinations
  • agitation
  • aggressive behavior
  • talking excessively
  • mania
  • nightmares
  • irritability
  • nonsensical talk
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • hypersexuality
  • tremors
  • walking difficulties
  • involuntary movements
  • decreased concentration
  • mental dullness
  • sweating
  • skin rash
  • eczema
  • itching
  • hives
  • vasodilation
  • sweating
  • thrombocytopenia

Not everyone experiences these, and they can vary from person to person.

Storage

This drug should be stored in a sealed container to prevent air from entering and kept at room temperature between 1°C and 30°C. Storing it this way can help maintain the drug's effectiveness for a long time.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.